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REST API Specifications (ITS-REST) Component v1.0.2
Category
Specification
Organisation
openEHR
Type
Standard
Version
1.0.2
Access
Open
Status
Active
Created
Dec-18
Updated
Apr-21
This document lays out the latest versions of REST API Specifications (ITS-REST) Component as at April 2021.
Simplified Data Template (SDT) vITS-REST 1.0.2
Category
Specification
Organisation
openEHR
Type
Standard
Version
ITS-REST 1.0.2
Access
Open
Status
Draft
Created
Jul-19
Updated
Mar-21
This document describes a simplified template (ST) format that enables easier creation of openEHR content.
Support Information Model vRM 1.1.0
Category
Specification
Organisation
openEHR
Type
Standard
Version
RM 1.1.0
Access
Open
Status
Active
Created
2019
Updated
Dec-19
This document describes the openEHR Support Information Model, whose semantics are used by all openEHR Reference Models.
Support Terminology Specification vTERM 3.0.0
Category
Specification
Organisation
openEHR
Type
Standard
Version
TERM 3.0.0
Access
Open
Status
Active
Created
Feb-23
Updated
Jun-23
This document describes the openEHR Support Terminology and code sets, which define the vocabulary and codes needed for the openEHR Reference, Archetype and Service models.
Task Planning (TP) Specification vPROC 1.6.0
Category
Specification
Organisation
openEHR
Type
Standard
Version
PROC 1.6.0
Access
Open
Status
Trial
Created
May-20
Updated
Dec-20
This specification of the openEHR Task Planning facility addresses clinical process automation requirements in which granular planning of clinical work is required.
Task Planning Visual Modelling Language (TP-VML) vPROC 1.6.0
Category
Specification
Organisation
openEHR
Type
Standard
Version
PROC 1.6.0
Access
Open
Status
Trial
Created
Jun-20
Updated
Nov-20
This document describes a visual modelling language for the openEHR Task Planning Model (TP-VML). This language is designed to enable visually efficient visual representations of Task Plans to be authored with appropriately configured tools.
XML Schemas (ITS-XML) Component v1.0.2
Category
Specification
Organisation
openEHR
Type
Standard
Version
1.0.2
Access
Open
Status
Active
Created
Nov-18
This document gives a high-level overview of the XML Schemas (ITS-XML) Component 1.0.2.
Best Practice Guideline
Category
Guideline
Organisation
Royal College of Pathologists of Australasia (RCPA)
Type
Standard
Access
Open
Status
Active
Created
Mar-21
This document sets out best-practice guidelines for the grouping of selected tests on rendered pathology reports in the areas of chemical pathology, anatomical pathology, genetic pathology, haematology, immunopathology and microbiology.
Standardised Pathology Informatics in Australia (SPIA) Guidelines v4.1
Category
Guideline
Organisation
Royal College of Pathologists of Australasia (RCPA)
Type
Standard
Version
4.1
Access
Open
Status
Active
Created
May-24
This document describes the guidelines around terminology, units, and rendering related to pathology requesting and reporting in Australia.
E-health web services profiles
Category
Standard
Organisation
Standards Australia
ID
AS 5550-2013
Type
Standard
Access
Fees apply to access
Status
Active
Created
Dec-13
This document describes the Simple Object Access Protocol (SOAP) web services specifications and a base set of specifications that define interoperable and secure web services for e-health.
Person and provider identification in healthcare
Category
Technical Specification
Organisation
Standards Australia
ID
AS 4846:2014
Type
Standard
Access
Fees apply to access
Status
Active
Created
Aug-14
This document provides the health industry with a standard for healthcare provider and individual identification data, which includes processes for clinical and administrative data management purposes (data structure, process and specification).
E-health XML secured payload profiles
Category
Technical Specification
Organisation
Standards Australia
ID
ATS 5821-2010
Type
Standard
Access
Fees apply to access
Status
Superseded
Created
Mar-10
This document describes how to represent digital signatures and how to encrypt data in XML.
E-health secure message delivery
Category
Technical Specification
Organisation
Standards Australia
ID
ATS 5822-2010
Type
Standard
Access
Fees apply to access
Status
Superseded
Created
Mar-10
This document describes a set of user interfaces and applications that support secure electronic message delivery between different healthcare providers.
ARGB Appendix 11 - Guidance on TGO 107: Standard for Biologicals – Labelling Requirements v2.0
Australian Regulatory Guidelines for Biologicals
Category
Supplimentary Resource
Organisation
TGA
Type
Standard
Version
2
Access
Open
Status
Active
Created
Sep-21
Updated
Feb-23
This document describes mandatory labelling requirements for biologicals and human cell and tissue (HCT) materials specifically for manufacturers, sponsors and providers of these materials, and should be read in conjunction with TGO 107.
Australian Regulatory Guidelines for Medical Devices (ARGMD)
Category
Guidance HTML
Organisation
TGA
Type
Standard
Access
Open
Status
Active
Updated
Nov-23
This guidance provides information on the import, export and supply of medical devices within Australia.
Digital tools and medical devices v1.0
Guidance for the mental health sector
Category
Guidance Document
Organisation
TGA
Type
Standard
Version
1
Access
Open
Status
Active
Updated
May-23
This document provides guidance for the mental health sector about when their digital tools, aids, apps and products, including internet-based services, may be regulated as medical devices by the TGA.
Electronic Instructions for Use – eIFU v1.0
For professional users of medical devices (including IVDs)
Category
Guidance Document
Organisation
TGA
Type
Standard
Version
1
Access
Open
Status
Active
Created
Aug-18
This guideline aims to support manufacturers and sponsors who supply instructions for use of their medical devices in an electronic or online format.
How to submit a custom-made medical device / patient-matched medical device notification v2.0
Step-by-step guide
Category
Guidance Document
Organisation
TGA
Type
Standard
Version
2
Access
Open
Status
Active
Updated
Dec-23
This document describes how to complete and submit custom-made medical device and patient-matched medical device transition notifications.
Medical device cyber security information for users v1.2
Consumers, health professionals, small business operators and large scale service providers
Category
Guidance Document
Organisation
TGA
Type
Standard
Version
1.2
Access
Open
Status
Active
Updated
Nov-22
This document describes cyber security practices and protocols for the medical device sector and aims to help medical device users manage cyber security risk.
Medical device patient information leaflets and implant cards (including acceptance of Implementation Plans) v1.9
Category
Guidance Document
Organisation
TGA
Type
Standard
Version
1.9
Access
Open
Status
Active
Created
Oct-22
Updated
May-23
This document aims to help manufacturers and sponsors understand the legislative requirements for patient information materials, such as patient implant cards and patient information leaflets, and how to comply with these requirements.
Medical device patient information materials: a fact sheet for health professionals
Category
Supplimentary Resource
Organisation
TGA
Type
Standard
Access
Open
Status
Active
Updated
May-23
This fact sheet for health professionals discusses providing patients with information about their medical devices. It discusses who is responsible for providing patient information leaflets (PILs) and patient implant cards (PICs) to patients, and when they should be supplied.
Regulation of software based medical devices
Category
Guidance HTML
Organisation
TGA
Type
Standard
Access
Open
Status
Active
Updated
Jul-24
This document provides information on the regulation in Australia for software and apps which meet the legislated definition of a medical device. It helps manufacturers and sponsors understand how the Therapeutic Goods Administration (TGA) interprets requirements, and how they can comply with the regulations.
Regulatory basics on medical devices for health practitioners v1.0
Category
Guidance Document
Organisation
TGA
Type
Standard
Version
V 1.0
Access
Open
Status
Active
Created
Mar-24
This guidance is for Australian health practitioners who manufacture, supply and use medical devices. It helps them identify whether their devices are regulated by the Therapeutic Goods Administration (TGA) and it also advises how to comply with the requirements of the therapeutic goods legislation.
Standard for serialisation and data matrix codes on medicines v1.0
Guidance for TGO 106
Category
Supplimentary Resource
Organisation
TGA
Type
Standard
Version
V 1.0
Access
Open
Status
Active
Created
Mar-21
This guidance is for sponsors and manufacturers supplying medicines in Australia that are serialised or have data matrix codes. It describes the requirements in the Therapeutic Goods (Medicines – Standard for Serialisation and Data Matrix Codes) (TGO 106) Order 2021.
ICD API Authentication
Category
Supplimentary Resource
Organisation
World Health Organization (WHO)
Type
Standard
Access
Open
Status
Active
This resource lays out the steps to use the ICD APIs, which allow programmatic access to the International Classification of Diseases (ICD).
ICD API Samples GitHub repository
Category
Supplimentary Resource
Organisation
World Health Organization (WHO)
Type
Standard
Access
Open
Status
Active
This GitHub repository contains samples for ICD API and other related repositories.
ICD-10 User Guide
Category
User guide
Organisation
World Health Organization (WHO)
Type
Standard
Access
Open
Status
Active
This user guide contains information on how to use the International Statistical Classification of Diseases and Related Health Problems 10th revision (ICD 10) online application.
ICD-10 Version:2019
Category
Specification
Organisation
World Health Organization (WHO)
Type
Standard
Version
2019
Access
Open
Status
Active
The International Statistical Classification of Diseases and Related Health Problems 10th revision (ICD-10 Version:2019) is part of the WHO Family of International Classifications (WHO-FIC) that allows all healthcare workers (and patients) to communicate using one (technical) language.
ICD-10 International statistical classification of diseases and related health problems. 10th revision. Volume 2 Instruction manual v6 2019
Category
Guidance Document
Organisation
World Health Organization (WHO)
Type
Standard
Version
43617
Access
Open
Status
Active
Created
2019
This instruction manual for the tenth revision of the International Statistical
Classification of Diseases and Related Health Problems (ICD-10) contains
guidelines for recording and coding, and instructions on practical aspects of the ICD’s use. However, users must also undergo formal training in the use of the ICD.
ICD-11 for Mortality and Morbidity Statistics
Category
Specification
Organisation
World Health Organization (WHO)
Type
Standard
Access
Open
Status
Active
Created
Jan-24
This webpage allows the user to search the ICD-11 mortality and morbidity statistics on diseases and related health problems for the condition/s they are interested in.
ICD-11 Browser User Guide
Category
User guide
Organisation
World Health Organization (WHO)
Type
Standard
Access
Open
Status
Active
ICD-11 Browser is a website that allows users to see the content of the International Statistical Classification of Diseases and Related Health Problems 11th revision (ICD-11). This user guide provides details on how to search the ICD-11 efficiently.
ICD-11 Coding Tool
Mortality and Morbidity Statistics (MMS)
Category
Supplimentary Resource
Organisation
World Health Organization (WHO)
Type
Standard
Access
Open
Status
Active
Created
Jan-24
This coding tool allows the user to search for specific diseases or related health problems in the International Statistical Classification of Diseases and Related Health Problems 11th revision (ICD-11) to obtain the ICD-11 code for the condition.
ICD-11 Implementation or Transition Guide v1.05
Category
Implementation Guide
Organisation
World Health Organization (WHO)
Type
Standard
Version
1.05
Access
Open
Status
Active
Created
2019
This guide is a part of the ICD-11 (International Statistical Classification of Diseases and Related Health Problems 11th revision) implementation package. The guide supports decisionmakers in planning the implementation of, or transition to, the new ICD-11 in their jurisdictions.
ICD-11 Reference Guide
International Classification of Diseases for Mortality and Morbidity Statistics 11th revision
Category
Guidance Document
Organisation
World Health Organization (WHO)
Type
Standard
Access
Open
Status
Active
Created
2022
The ICD-11 is the latest (11th) revision of the International Classification of Diseases (ICD). This reference guide presents an introduction to ICD-11 and provides guidance on its use.
ICD-API v2
Category
Specification
Organisation
World Health Organization (WHO)
Type
Standard
Version
2
Access
Open
Status
Active
Created
2019
Updated
Jan-24
ICD API is an HTTP-based REST API that allows programmatic access to the International Classification of Diseases (ICD). This document and the API-Reference is for software developers who would like to consume the ICD-API in their software.
Environmental Sustainability and Climate Resilience Healthcare Module
Draft version
Category
Supplimentary Resource
Organisation
ACSQHC
ID
D23-51832
Type
Standard
Access
Open
Status
Draft
Created
Nov-23
The document provides a framework of environmental sustainability and climate resilience actions that use a health service organisation’s existing governance, safety and quality systems.
An Introduction to Artificial Intelligence
Category
Guidance Document
Organisation
Australian Signals Directorate’s Australian Cyber Security Centre (ASD’s ACSC)
Type
Standard
Access
Open
Status
Active
Created
Nov-23
This document provides readers with an understanding of what artificial intelligence (AI) is and how it may impact the digital systems and services they use.
An Introduction to Securing Smart Places
Category
Guidance Document
Organisation
Australian Signals Directorate’s Australian Cyber Security Centre (ASD’s ACSC)
Type
Standard
Access
Open
Status
Active
Created
Nov-22
Smart places are places that use smart technology (IT)-enabled systems to provide enhanced services to citizens. This document explores the key security risks of smart places and ways to mitigate risk.
Engaging with Artificial Intelligence
Category
Guidance Document
Organisation
Australian Signals Directorate’s Australian Cyber Security Centre (ASD’s ACSC)
Type
Standard
Access
Open
Status
Active
Created
Jan-24
This document provides organisations with guidance on how to use artificial intelligence (AI) systems securely.
IoT Secure-by-Design Guidance for Manufacturers
Category
Guidance Document
Organisation
Australian Signals Directorate’s Australian Cyber Security Centre (ASD’s ACSC)
Type
Standard
Access
Open
Status
Active
Created
Sep-20
This document provides cyber security guidance for manufacturers of Internet of Things (IoT) devices, such as drones, security cameras, smart televisions, solar inverters and other ‘smart’ devices.
Strategies to Mitigate Cyber Security Incidents – Mitigation Details
Category
Guidance Document
Organisation
Australian Signals Directorate’s Australian Cyber Security Centre (ASD’s ACSC)
Type
Standard
Access
Open
Status
Active
Created
Feb-10
Updated
Feb-17
This document helps organisations mitigate cyber security incidents caused by targeted cyber intrusions, ransomware, malicious insiders, business email compromise and threats to industrial control systems.
GS1 Architectural Principles
Category
Specification
Organisation
GS1
Type
Standard
Version
4
Access
Open
Status
Active
Created
Jun-20
This document sets out the architectural principles that underpin the GS1 system.
GS1 System Architecture
Category
Specification
Organisation
GS1
Type
Standard
Version
11.1
Access
Open
Status
Active
Created
Mar-23
The GS1 system is the collection of standards, guidelines, solutions, and services created by the GS1 community. This document defines and describes the architecture of the GS1 system of standards.
GS1 Pharmaceutical Clinical Trial Electronic Messaging Standard Implementation Guideline
Category
Implementation Guide
Organisation
GS1
Type
Standard
Version
1.2
Access
Open
Status
Active
Created
Jun-23
This guideline details the best-practice approach to implementing GS1 standards for electronic messaging in the pharmaceutical clinical trial supply chain.
GS1 Pharmaceutical Image Implementation Guideline
Category
Implementation Guide
Organisation
GS1
Type
Standard
Version
1
Access
Open
Status
Active
Created
Jun-17
This document provides a method of image naming for pharmaceutical products to increase efficiencies and minimise costs.
GS1 Product Image Specification Standard
Category
Standard
Organisation
GS1
Type
Standard
Version
4.4
Access
Open
Status
Active
Created
Apr-24
This standard establishes rules for the storage of digital images associated with products. It covers images such as barcodes and labels as well as photographic and rendered product images.
GS1 Third-Party Data Exchange in Healthcare – Implementation guide
Category
Implementation Guide
Organisation
GS1
Type
Standard
Version
2
Access
Open
Status
Active
Created
Feb-15
This document provides guidance for serialised data exchange between contract manufacturing organisations, third-party manufactures, contract packagers, and the manufacturers who use these partners.
HL7 Arden Syntax for Medical Logic Systems, Edition 3.0
Category
Standard
Organisation
HL7
ID
ARDEN _E3.0_STU_2023DEC
Type
Standard
Version
3
Access
Open
Status
Trial
Created
Dec-23
This standard defines a syntax for creating and sharing computerised health knowledge bases.